An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-07-31

Brief Summary

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The purpose of this study is to compare of difference in NRS scores from baseline to the completion of treatment (5 days) in patients with administration of morphine sulfate versus oxycodone hydrochloride.

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Detailed Description

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5days, Multi-centers, Randomization, Open label, Parallel, Active Comparator, Phase 4 Study.

Conditions

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Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Oxycodone Hydrochloride

Brand Name: OxyNorm® Generic name: Oxycodone hydrochloride

Group Type EXPERIMENTAL

Oxycodone Hydrochloride

Intervention Type DRUG

Oxycodone injection

Morphine Sulphate

Brand name: BC Morphine sulfate Generic name: Morphine sulfate

Group Type ACTIVE_COMPARATOR

Morphine Sulphate

Intervention Type DRUG

Morphine sulphate injection

Interventions

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Oxycodone Hydrochloride

Oxycodone injection

Intervention Type DRUG

Morphine Sulphate

Morphine sulphate injection

Intervention Type DRUG

Other Intervention Names

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Oxynorm BC morphine

Eligibility Criteria

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Inclusion Criteria

1. Adult men and women aged 19 years or more
2. Patients with cancerous pain who are hospitalized or scheduled for hospitalization at Screening and not planned to be discharged during the study
3. Patients with mean moderate to severe pain over the past 7 days at Screening as verbally confirmed (NRS 4 or higher)
4. Subjects who voluntarily signed the Informed Consent Form for the study
5. Subjects who are capable of understanding details of the study and verbal communication on pain intensity

Exclusion Criteria

1. Patients who reached the narcotic analgesic dose corresponding to the followings for cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day, oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)
2. Patients with a medical history of hypersensitivity to an ingredient of oxycodone hydrochloride or morphine sulfate or other narcotic analgesics
3. Patients who have contraindications and cautions when study drugs administered.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No